Cleared Traditional

K935728 - DYNATRON 150

K935728 is the FDA 510(k) clearance for DYNATRON 150 by Dynatronics Corp.. It is a Class 2 Physical Medicine device (product code IMG) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K935728 · Dynatronics Corp. · Physical Medicine device
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Apr 1994
Decision
146d
Days
Class 2
Risk

K935728 is an FDA 510(k) clearance for the DYNATRON 150. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Dynatronics Corp. devices

Submission Details

510(k) Number K935728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1993
Decision Date April 26, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 115d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 14
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K935728.
FORTE
K953614 · Chattanooga Group, Inc. · Oct 1995
FORTE CB
K951746 · Chattanooga Group, Inc. · Jun 1995
FORTE US
K941561 · Chattanooga Group, Inc. · Jun 1994
FORTE US
K940180 · Chattanooga Group, Inc. · Apr 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935271 · Chattanooga Group, Inc. · Feb 1994
INTELECT, MODEL 245
K911733 · Chattanooga Group, Inc. · Dec 1991